K043027 is an FDA 510(k) clearance for the MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Applied Medical Technology, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 2, 2004, 29 days after receiving the submission on November 3, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K043027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 03, 2004 |
| Decision Date | December 02, 2004 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |